CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Detachable Pend Fru-1 Pend component recalled by Mobius Imaging

Mobius Imaging is recalling Detachable Pend Fru-1 Pend component for the Airo Computed Tomography (CT) X-ray System, distributed nationwide in the US. The recall was initiated on 4 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373, 2303430383, 2303430393, 2304034583, 2304034593, 2304034603, 2304034613, 2304034623, 2305514123, 2305514133, 2305514143, 2305514153, 2311019263, 2315101273, 2315101283, 2315101293, 2315101303, 2316030903, 2316030913, 2316703793, 2316703803, 2316703813, 2316703823, 2317415513, 2317415523, 2317415533, 2317415543, 2317415553, 2317905083, 2317905093, 2317905103, 2317905113, 2317905123, 2323513673, 2323513683, 2323513693, 2331419663, 2331419673, 2332117403, 2332117413, 2332117423, 2332117433, 2332117443, 2333404593, 2333404603, 2335506763, 2335506773, 2401909563, 2401909573, 2401909583, 2401909593, 2401909603, 2401909613, 2402911603, 2402911613, 2402911623, 2402911633, 2404302243, 2404302253, 2404302263, 2404302273, 2409620273, 2409620283, 2409620293, 2409620303, 2422207853, 2422207863, 2422207873, 2422207883, 2422207893, 2422207903, 2422207913, 2426303233, 2426303243, 2426303253, 2426303263, 2426303273, 2426303283, 2431210783, 2431210793, 2431210803, 2431210813, 2431210823, 2434504553, 2434504563, 2434504573, 2502103553, 2502103583, 2502103593, 2503121733, 2503121743, 2503121753, 2503616113, 2503616123, 2503616133, 2503616213.

Quantity recalled101 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1040-2026
FDA event ID: 98099
Recalling firm: Mobius Imaging, Shirley, MA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Dec 2025
FDA classified: 9 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

4 Dec 2025	Recall initiated by company
9 Jan 2026	Classified by FDA	+36 days
21 Jan 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Product as listed by the FDA

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

Where it was distributed

US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Illinois Kentucky Massachusetts Maryland Michigan Minnesota Missouri North Carolina New York Ohio Pennsylvania Rhode Island

Questions about this recall

Why was it recalled?

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Which lots are affected?

Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373, 2303430383, 2303430393, 2304034583, 2304034593, 2304034603, 2304034613, 2304034623, 2305514123, 2305514133, 2305514143, 2305514153, 2311019263, 2315101273, 2315101283, 2315101293, 2315101303, 2316030903, 2316030913, 2316703793, 2316703803, 2316703813, 2316703823, 2317415513, 2317415523, 2317415533, 2317415543, 2317415553, 2317905083, 2317905093, 2317905103, 2317905113, 2317905123, 2323513673, 2323513683, 2323513693, 2331419663, 2331419673, 2332117403, 2332117413, 2332117423, 2332117433, 2332117443, 2333404593, 2333404603, 2335506763, 2335506773, 2401909563, 2401909573, 2401909583, 2401909593, 2401909603, 2401909613, 2402911603, 2402911613, 2402911623, 2402911633, 2404302243, 2404302253, 2404302263, 2404302273, 2409620273, 2409620283, 2409620293, 2409620303, 2422207853, 2422207863, 2422207873, 2422207883, 2422207893, 2422207903, 2422207913, 2426303233, 2426303243, 2426303253, 2426303263, 2426303273, 2426303283, 2431210783, 2431210793, 2431210803, 2431210813, 2431210823, 2434504553, 2434504563, 2434504573, 2502103553, 2502103583, 2502103593, 2503121733, 2503121743, 2503121753, 2503616113, 2503616123, 2503616133, 2503616213.

Where was it sold?

US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98099

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026	CLASS II	Detachable Pendant Upgrade component recalled by Mobius Imaging	Mobius Imaging	Other	Nationwide

More recalls from Mobius Imaging

All 7

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Device	CLASS II	Detachable Pendant Upgrade component recalled by Mobius Imaging	Mobius Imaging	Other	Nationwide
25 Jan 2023Device	CLASS II	MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging	Mobius Imaging	Other	Nationwide
7 Dec 2022Device	CLASS II	MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging	Mobius Imaging	Device Malfunction	CO, TN, UT
26 Sep 2018Device	CLASS II	AIRO Mobile CT System recalled by Mobius Imaging	Mobius Imaging	Device Malfunction	MA
7 Mar 2018Device	CLASS II	AIRO Mobile CT System recalled by Mobius Imaging	Mobius Imaging	Device Malfunction	Nationwide

Other Imaging Equipment recalls

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7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide